Product Code: BZR FDA class 2 21 CFR 868.5330

Mixer, Breathing Gases, Anesthesia Inhalation

Anesthesiology

The Mixer, Breathing Gases, Anesthesia Inhalation is a device that blends specified concentrations of anesthetic and non-anesthetic gases for delivery to a patient during inhalation anesthesia, allowing precise control over the inspired gas composition. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZR, regulated under 21 CFR 868.5330 in the Anesthesiology specialty. This device is designated as life-sustaining or life-supporting and is eligible for third-party 510(k) review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code BZR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: BZR
Device Class: FDA class 2
Regulation Number: 868.5330
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 55 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243917	F&P Optiflow Air/Oxygen Flow Source	Jul 14, 2025	Substantially Equivalent	Fisher & Paykel Healthcare, Ltd.
K241465	Midas Flowmeter; eAVS	Sep 19, 2024	Substantially Equivalent	Parker Hannifin Corporation
K231895	Maxtec MaxBlend2+p	Dec 04, 2023	Substantially Equivalent	Maxtec, LLC
K230987	FlowStar Analog Mixer Flowmeter	Sep 14, 2023	Substantially Equivalent	Baldus Sedation GmbH & Co. KG
K222794	FlowStar Touch Digital Mixer Flowmeter	Jul 28, 2023	Substantially Equivalent	Baldus Sedation GmbH & Co. KG
K221494	Quality Mix Blender, Oxymixer	Jan 23, 2023	Substantially Equivalent	Dehas Medical Systems GmbH
K202480	Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50	Apr 22, 2021	Substantially Equivalent	Parker Hannifin
K173205	Equinox Advantage	Aug 29, 2018	Substantially Equivalent	O-Two Medical Technologies, Inc.
K161718	MaxBlend 2, MaxBlend Lite	Oct 27, 2016	Substantially Equivalent	Maxtec, LLC
K142291	GMX Series Medical Air/Oxygen Blender	May 19, 2015	Substantially Equivalent	Gentec (Shanghai) Corporation
K113687	EQUINOX RELIEVE	Apr 30, 2012	Substantially Equivalent	O-Two Medical Technologies, Inc.
K113232	MAXMIXING BLOCK	Mar 01, 2012	Substantially Equivalent	Maxtec, Inc.
K101286	SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04	Oct 20, 2011	Substantially Equivalent	Linde Healthcare AB
K103317	RESUSCITATION UNIT 105	Apr 20, 2011	Substantially Equivalent	Atom Medical Corporation
K092484	HELIOX LOW FLOW SENTRY BLENDER	Apr 02, 2010	Substantially Equivalent	Cardinal Health 207, Inc.
K090781	HELIO2 BLENDER	Aug 13, 2009	Substantially Equivalent	Precision Medical, Inc.
K081335	TENACORE OXYGEN BLENDER, MODEL TB-2000	Nov 14, 2008	Substantially Equivalent	Tenacore Holdings, Inc.
K053232	PRECISION BLENDER	Jan 10, 2006	Substantially Equivalent	Precision Medical, Inc.
K051192	PRAXAIR MEDICAL AIR MIXER	Sep 06, 2005	Substantially Equivalent	Praxair, Inc.
K050381	CS MEDICAL TTCF GAS DELIVERY SYSTEM	Jul 13, 2005	Substantially Equivalent	Cs Medical, Inc.
K031860	SK MED ME202 MONITORING MIXER	Jan 21, 2004	Substantially Equivalent	Sk Med
K031707	SK MED M201 PLUS MIXER	Aug 01, 2003	Substantially Equivalent	Sk Med
K022864	SK MED M201 MIXER	Apr 11, 2003	Substantially Equivalent	Sk Med
K001609	MALLARD AIR OXYGEN ACCUBLENDER	Aug 10, 2000	Substantially Equivalent	Mallard Medical, Inc.
K992503	SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES	Aug 10, 1999	Substantially Equivalent	Sechrist Industries, Inc.
K990293	ALADDIN II MONITORING OXYGEN/AIR MONITOR	Mar 16, 1999	Substantially Equivalent	Hamilton Medical, Inc.
K973646	BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER	May 07, 1998	Substantially Equivalent	Bird Products Corp.
K974372	AIR OXYGE MIXER	Feb 05, 1998	Substantially Equivalent	Sk Med
K960359	ALADDIN MONITORING OXYGEN/AIR MIXER	Apr 24, 1996	Substantially Equivalent	Hamilton Medical, Inc.
K953711	AIR ENTRAINER 900RT008	Nov 08, 1995	Substantially Equivalent	Fisher & Paykel Electronics , Ltd.
K952878	OXY/STAR LOW FLOW BLENDER	Sep 25, 1995	Substantially Equivalent	Infrasonics Corp.
K952021	PRIMA HYUPERINFLATION SYSTEM	May 22, 1995	Substantially Equivalent	Prima, Inc.
K943797	BABYCARE NEO2 OXYGEN CONCENTRATION CONTROLLER	May 11, 1995	Substantially Equivalent	Bpr Medical, Ltd.
K925982	BMD AIR/OXYGEN BLENDER	Oct 07, 1993	Substantially Equivalent	Biomedical Devices, Inc.
K925591	MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST	Sep 16, 1993	Substantially Equivalent	Merit Medical Systems, Inc.
K932709	PRECISION MED PRODUCTS LTD HYPERINFLATION SYSTEM	Jul 23, 1993	Substantially Equivalent	Precision Med Products, Ltd.
K932557	HYPERINFLATION SYSTEM	Jul 22, 1993	Substantially Equivalent	Life Shield Healthcare Products, Inc.
K911962	BIRD SENTRY AIR/OXYGEN MICROBLENDER	Oct 08, 1991	Substantially Equivalent	Bird Products Corp.
K900722	LOW FLOW N2O/02O MICROBLENDER	Jul 18, 1990	Substantially Equivalent	Bird Products Corp.
K895695	BIRD MICROBLENDER M.R.I.	Jul 06, 1990	Substantially Equivalent	Bird Products Corp.
K883833	NITRONOX(R), FIRST RESPONSE NITRONOX(TM)	Feb 17, 1989	Substantially Equivalent	Matrix Medica, Inc.
K883038	P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER	Nov 16, 1988	Substantially Equivalent	Bird Products Corp.
K872278	SIEMENS O2-AIR MIXER 965	Sep 03, 1987	Substantially Equivalent	Siemens Elema AB
K854769	LNI MGV MEDICAL GAS MIXER	Jun 05, 1986	Substantially Equivalent	P.A. Mccauley, Inc.
K860373	THE M100 AIR/OXYGEN MIXER	May 21, 1986	Substantially Equivalent	Newport Medical Instruments, Inc.
K853905	OHMEDA OXYGEN BLENDER	Oct 16, 1985	Substantially Equivalent	Ohmeda Medical
K841789	SECHRIST AIR-OXYGEN MIXER & ANCILLARY	Jul 26, 1984	Substantially Equivalent	Shiley, Inc.
K811393	DOWNS CAP FLOW GENERATOR	Jun 09, 1981	Substantially Equivalent	Vital Signs, Inc.
K802226	SECHRIST SERIES 3500 AIR-OXYGEN MIXER	Sep 26, 1980	Substantially Equivalent	Sechrist Industries, Inc.
K800866	ROYAL	May 28, 1980	Substantially Equivalent	Trident Dental, Inc.
K800865	WINDSOR	May 23, 1980	Substantially Equivalent	Trident Dental, Inc.
K800905	SIEMENS-ELEMA AB O2-AIR MIXER 960	May 08, 1980	Substantially Equivalent	Siemens Elema AB
K800764	DRAGER ORMC	Apr 29, 1980	Substantially Equivalent	Draeger Medical, Inc.
K760766	PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER	Oct 08, 1976	Substantially Equivalent	Fraser Sweatman, Inc.
K760017	CONSIOUS SEDATION (ANALOR P-76)	Jul 20, 1976	Substantially Equivalent	Mckesson Corp.